K-Binder Averts Hyperkalemia Over One Month: Top-Line Results

September 24, 2014

COPPELL, TX — Preliminary analysis of a phase 3 study suggests that oral treatment with the potassium-absorbing zirconium silicate compound ZS-9 (ZS Pharma) cuts the prevalence of recurrent hyperkalemia over 28 days, according to a company statement released primarily for the investment community[1].

The Hyperkalemia Randomized Intervention Multi-Dose ZS-9 Maintenance (HARMONIZE) study enrolled 258 patients with hyperkalemia associated with chronic kidney disease (CKD), heart failure (HF), diabetes, and/or chronic therapy with agents that block the renin-angiotensin-aldosterone system (RAAS). The trial included open-label and randomized phases.

Hyperkalemia is a well-known side effect of some RAAS-blocking agents and can be an impediment to using them fully.

Side effects in HARMONIZE resembled those in other ZS-9 clinical studies, according to ZS Pharma. Those studies included another phase 3 trial, different parts of which have been recently reported by heartwire , that found the ZS-9 safety profile to be "comparable to placebo."

The company says it "plans to file a new drug application with the United States Food and Drug Administration and a marketing authorization application with the European Medicines Agency in the first half of 2015."


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